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General MedicationsINTRAVENOUSStandard

XACDURO (COPACKAGED)

DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM

Standard Dose
EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview XACDURO (COPACKAGED) is listed in Drugs@FDA under application 216974 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM Form and strength POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL Sponsor ENTASIS THERAP Submission history Latest submission status date: 2023-05-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview XACDURO (COPACKAGED) is listed in Drugs@FDA under application 216974 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM Form and strength POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL Sponsor ENTASIS THERAP Submission history Latest submission status date: 2023-05-23 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.